Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DRJ · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832828 | CENTURION CARDIAC DETECTOR | Clinical Data Instruments, Inc. | 1984-05-09 | 264 | 0 |
| K822590 | PRESSURE ISOLATION AMPLIFIER #9813 517 | Honeywell, Inc. | 1982-10-04 | 27 | 0 |
| K771684 | AMPLIFIER MODEL N5A-ECG | Honeywell, Inc. | 1977-09-14 | 8 | 0 |
| K771685 | AMPLIFIER MODEL N5A-HIS | Honeywell, Inc. | 1977-09-14 | 8 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda